PVC and phthalates in PVC and phthalates in medical devicesmedical devices

- a historical case - a historical case studystudy

Ole Grøndahl HansenOle Grøndahl HansenPVC Information Council DenmarkPVC Information Council Denmark

Plastics in Medical Devices ConferencePlastics in Medical Devices ConferenceBrussels 9 – 10 April 2008Brussels 9 – 10 April 2008

ContentContent

PVC based medical devices – the basicsPVC based medical devices – the basics PVC under pressure in the nineties – a case study of a converterPVC under pressure in the nineties – a case study of a converter Study on medical tubingStudy on medical tubing A European perspectiveA European perspective Health concerns around the change of the centuryHealth concerns around the change of the century Alternatives to DEHP in medical devices Alternatives to DEHP in medical devices ConclusionsConclusions

others 11%

PP 13%

PS 21%PE 29%

PVC 29%

Use of plastics in the health care sector

85.000 tons of PVC used for medical devices per year in EU

Total consumption of PVC in Europe is 7.000.000 tons

PVC medical applicationsPVC medical applications

The low costs and the high performance of PVC made it The low costs and the high performance of PVC made it possible to manufacture single-use devices in the late possible to manufacture single-use devices in the late 1950’ties. 1950’ties.

The two main application areas for PVC devices are flexible The two main application areas for PVC devices are flexible containers and medical tubing: ie. urine bags, ostomy bags, containers and medical tubing: ie. urine bags, ostomy bags, bloodbags etc and different kinds of tubing for catheters bloodbags etc and different kinds of tubing for catheters etc.etc.

Single-use of medical devices resulted in a revolution within Single-use of medical devices resulted in a revolution within the health care sector. The PVC based devices improved the health care sector. The PVC based devices improved medical safety by reducing the risk of life-threatening medical safety by reducing the risk of life-threatening infections caused by the multiple-use of traditional devices.infections caused by the multiple-use of traditional devices.

Case study of a Case study of a subcontractorsubcontractor

As a subcontractor, Totax Plastic’s 60 employees are manufacturing medical tubing used in hospitals worldwide.

Company turnover is 7 million €

In the late 1980’ties, PVC was under heavy pressurein Denmark. The main accusations were:

PVC under heavy pressurePVC under heavy pressure

1.1. ”Incineration of PVC ”Incineration of PVC causes heavy dioxin causes heavy dioxin emissions resulting in emissions resulting in dioxins in mother’s dioxins in mother’s milk”.milk”.

2.2. ””Incineration of PVCIncineration of PVCcauses acid rain causes acid rain resulting in dead resulting in dead forests”.forests”.

Danish Minister of Danish Minister of Environment in 1990: Environment in 1990: ”In principle I want to ”In principle I want to ban PVC.”ban PVC.”The conditions of existence of the company

was threatened because of the PVC-debate. Above Danish newspaper article in 1990.

”Possibilities for PVC substitution in certain medical devices”

Report from the Danish EnvironmentalProtection Agency, Copenhagen 1991

Decisive report from Danish EPADecisive report from Danish EPA

Together with the Danish Technological Institute and the Danish EnvironmentalProtection Agency, Totax Plastic carried out a comprehensive study on medical tubing in 1991.The result was the report:

Requirements for medical tubingRequirements for medical tubing

First step in the study was to show First step in the study was to show the requirements to medicalthe requirements to medicaltubing. Which are:tubing. Which are:

1. Flexibility and softness1. Flexibility and softness2. Anti-kink characteristics2. Anti-kink characteristics3. Strength/memory3. Strength/memory4. Transparency4. Transparency5. Easy to sterilise5. Easy to sterilise6. Surface morphology6. Surface morphology7. Ability to link7. Ability to link8. Ease of fabrication8. Ease of fabrication9. Easy to use9. Easy to use10. Cost-effectiveness10. Cost-effectiveness

The studyThe study

81 different existing non-PVC types of plastics were 81 different existing non-PVC types of plastics were tested tested

– In particular none of the tested materials could meet the anti-In particular none of the tested materials could meet the anti-kink characteristics of the PVC-tubing.kink characteristics of the PVC-tubing.

– All the tested materials were more expensive than the PVC All the tested materials were more expensive than the PVC compoundcompound

– None of the alternative alternatives were tested for emissions None of the alternative alternatives were tested for emissions in association with incinerationin association with incineration

Anti-kink characteristics are Anti-kink characteristics are essential for PVC medical tubingessential for PVC medical tubing

Kinking means a fold on the tubing, which narrows and stops the passage

The non-kinking characteristic is the most important requirement made to materials meant for manufacturing of tubing in medical devices.

The chemical structure of PVC is the only one ensuring effective anti-kink characteristics”.

Kinking may cause serious complications and life threatening situations for the patient.

Overall conclusions of the Danish Overall conclusions of the Danish EPA study from 1991EPA study from 1991

TechnicallyTechnically: PVC is a superior material. All requirements to a medical : PVC is a superior material. All requirements to a medical tubing can only be met at the same time by using PVCtubing can only be met at the same time by using PVC

EconomicallyEconomically: PVC is a superior material. PVC is simply the most cost : PVC is a superior material. PVC is simply the most cost effective plastic material on the market.effective plastic material on the market.

EnvironmentallyEnvironmentally: In the study the alternative materials were not : In the study the alternative materials were not tested environmentally in any way. The study therefore did not tested environmentally in any way. The study therefore did not state any conclusions as to whether the environmental state any conclusions as to whether the environmental performance of the alternatives was better or worse than PVCperformance of the alternatives was better or worse than PVC..

Because of the results of the EPA medical tubing study, the Because of the results of the EPA medical tubing study, the continued use of PVC medical tubing was secured in Denmark.continued use of PVC medical tubing was secured in Denmark.

For ostomy bags a similar study was carried out, the conclusion of For ostomy bags a similar study was carried out, the conclusion of which was that no material could meet the performance of PVC which was that no material could meet the performance of PVC when it came to odour and noise properties.when it came to odour and noise properties.

New knowledge and new New knowledge and new technology changed the debatetechnology changed the debateTHEN:THEN:

In the past badly driven hospital incinerators caused acid rain and In the past badly driven hospital incinerators caused acid rain and dioxin emissions. This was partly due to the chlorine content in the dioxin emissions. This was partly due to the chlorine content in the hospital waste. Although PVC is only one of the contributors of hospital waste. Although PVC is only one of the contributors of chlorine PVC was accused of being the main cause of these chlorine PVC was accused of being the main cause of these emissions.emissions.

NOW:NOW:Because of new incineration technologies and more stringent Because of new incineration technologies and more stringent regulations, PVC plays no longer any role in the creation of acid rain regulations, PVC plays no longer any role in the creation of acid rain and cannot be accused of being the cause of dioxin emissions. The and cannot be accused of being the cause of dioxin emissions. The dioxin debate during the last ten years showed that the role of PVC is dioxin debate during the last ten years showed that the role of PVC is secondary to incinerator design and operating conditions in the secondary to incinerator design and operating conditions in the creation of dioxins from waste incinerators.”creation of dioxins from waste incinerators.”

The concern of dioxin in association with the incineration of medical The concern of dioxin in association with the incineration of medical devices has diminished dramatically during the last ten years. This is devices has diminished dramatically during the last ten years. This is partly because of new scientific knowledge partly because of the use partly because of new scientific knowledge partly because of the use of new incineration technology. However, neutralisation residues of new incineration technology. However, neutralisation residues resulting of PVC incineration is still of concern to some stakeholders.resulting of PVC incineration is still of concern to some stakeholders.

The EU perspectiveThe EU perspective

Initiated by the Danish Environment Commissioner Ritt Bjerregaard, the EU-Initiated by the Danish Environment Commissioner Ritt Bjerregaard, the EU-systems gets involved in the PVC issue in the late 90’ties.systems gets involved in the PVC issue in the late 90’ties.

A Horizontal initiative, a Green Paper on PVC and a EU-resolution from the A Horizontal initiative, a Green Paper on PVC and a EU-resolution from the Parliament dominate the PVC debate around the turn of the 21st century.Parliament dominate the PVC debate around the turn of the 21st century.

In 2000 the PVC industry establishes the Voluntary Committment of the whole In 2000 the PVC industry establishes the Voluntary Committment of the whole PVC supply chain called Vinyl 2010. Vinyl 2010 is taking responsible care of PVC supply chain called Vinyl 2010. Vinyl 2010 is taking responsible care of emissions, recycling, additives and new waste management technology.emissions, recycling, additives and new waste management technology.

EU-Parliament votingEU-Parliament voting

In 2007 there is a vote on PVC in the European Parliament. 662 vote against a PVC directive, while 17 vote for. PVC is not an issue anymore in the European Parliament. According to the EU Commission the reason is the industry’s voluntary committment: Vinyl 2010

New ConcernsNew Concerns

Earlier PVC as a material was of concern because of Earlier PVC as a material was of concern because of environmental issues. Now the concern is connected to environmental issues. Now the concern is connected to health and consequently the use of additives. The use of health and consequently the use of additives. The use of phthalates in medical devices is now in focus.phthalates in medical devices is now in focus.

The reason for this shift is partly because of the so called The reason for this shift is partly because of the so called hormone disrupting chemicals. Especially the Danish hormone disrupting chemicals. Especially the Danish medical professor Niels Erik Skakkebæk’s hypotesis saying medical professor Niels Erik Skakkebæk’s hypotesis saying that hormone disrupting chemicals cause detrimental that hormone disrupting chemicals cause detrimental effects in humans is a world wide issue. DEHP is accused of effects in humans is a world wide issue. DEHP is accused of being a hormone disrupting chemical.being a hormone disrupting chemical.

For many medical device companies manufacturing DEHP-For many medical device companies manufacturing DEHP-based devices a search for alternatives to DEHP begins. based devices a search for alternatives to DEHP begins.

Study on alternatives to DEHP in Study on alternatives to DEHP in 20032003

””Evaluation of plasticisers for PVC medical devices”. Danish Evaluation of plasticisers for PVC medical devices”. Danish EPA study from 2003. Together with Totax Plastic A/S, EPA study from 2003. Together with Totax Plastic A/S, Unomedical A/S and Papyrotex A/S. PVC Information Council Unomedical A/S and Papyrotex A/S. PVC Information Council DK also participated in the study.DK also participated in the study.

Conclusions:Conclusions:

Extensive effort is needed before one can decide to Extensive effort is needed before one can decide to substitute any other plasticiser for DEHPsubstitute any other plasticiser for DEHP

Much more data on the potential alternatives are needed Much more data on the potential alternatives are needed before DEHP can be seriously substituted in medical before DEHP can be seriously substituted in medical devicesdevices

Latest study from EU CommissionLatest study from EU Commission

Scientific Committee on Emerging and Newly-Identified Health Scientific Committee on Emerging and Newly-Identified Health RisksRisks

(SCENIHR)(SCENIHR)

THE SAFETY OF MEDICAL DEVICES CONTAINING DEHP PLASTICIZEDPVC OR OTHER PLASTICIZERS ON NEONATES AND

OTHER GROUPS POSSIBLY AT RISK

Approved for public consultation by the SCENIHR during the 19th plenary of June2007

SCENIHR conclusions (I)SCENIHR conclusions (I)

There is limited evidence indicating a relation between DEHP There is limited evidence indicating a relation between DEHP exposures and specific effects in humans.exposures and specific effects in humans.

However:However:

New information indicates that there is reason for concern for New information indicates that there is reason for concern for premature born male neonates. Other population groups at risk are premature born male neonates. Other population groups at risk are those requiring repeated medical procedures and male infants and those requiring repeated medical procedures and male infants and

male foetuses of pregnant women.male foetuses of pregnant women.

SCENIHR conclusions (II)SCENIHR conclusions (II)

There are alternative plasticizers to PVC and also non-PVC There are alternative plasticizers to PVC and also non-PVC alternative materials available (The non-PVC alternative materials alternative materials available (The non-PVC alternative materials were not evaluated in the study). For the alternative plasticizers a were not evaluated in the study). For the alternative plasticizers a generic exposure assessment could not be performed, due to lack generic exposure assessment could not be performed, due to lack of data.of data.

Some alternatives may be suitable to replace DEHP in certain Some alternatives may be suitable to replace DEHP in certain medical devices, while for other devices it may be difficult to medical devices, while for other devices it may be difficult to obtain the same functionalities as PVC plasticised with DEHPobtain the same functionalities as PVC plasticised with DEHP

The risk and benefit should be carefully evaluated according to The risk and benefit should be carefully evaluated according to established protocols, for each individual medical device and each established protocols, for each individual medical device and each medical procedure in which the alternatives are intended to be medical procedure in which the alternatives are intended to be used.used.

Overall conclusions todayOverall conclusions today

Technically and economically PVC is a superior material for the Technically and economically PVC is a superior material for the manufacturing of medical devices.manufacturing of medical devices.

Because of Vinyl 2010 and because of EU implementation of new Because of Vinyl 2010 and because of EU implementation of new incineration technologies PVC should no longer be an issue of incineration technologies PVC should no longer be an issue of environmental concern.environmental concern.

For sensitive medical applications alternatives to DEHP now exist. For sensitive medical applications alternatives to DEHP now exist. The benefits of a PVC product can be maintained by choosing The benefits of a PVC product can be maintained by choosing among different kinds of plasticisers.among different kinds of plasticisers.

DINCH, Soft ’n Safe, adipate plasticisers, trimellitates and DINCH, Soft ’n Safe, adipate plasticisers, trimellitates and polymerics are good examples.polymerics are good examples.

THANK YOU!THANK YOU!